Compositions and methods for controlling the weight of animals

ABSTRACT

Compositions are provided comprising a balance between lysine and essential amino acids and metabolizable energy. The compositions are useful in methods to prevent or treat obesity in an animal without concomitant loss of lean muscle mass. The compositions may also be used in methods to preserve or to cause a gain in lean muscle mass in an animal in need thereof.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a US filing under 35 USC 371 of InternationalApplication No. PCT/US2007/062710 filed on Feb. 23, 2007, the contentsof which are incorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to compositions and methods for controlling theweight of animals.

BACKGROUND OF THE INVENTION

Animals, particularly companion animals (e.g., dogs and cats), may weighmore than their ideal body weight. Having an excess of adipose tissue,these animals may be clinically diagnosed as, e.g., “fat”, “overweight”,or “obese” and, as such, are more likely to suffer from associatedphysical disorders such as arthritis, heart disease, respiratorydisease, diabetes, bladder cancer, hypothyroidism, joint disease and/orpancreatitis.

Attempts to prevent or reduce the amount of excess adipose tissue oncompanion animals typically include dietary restriction and exercise.Indeed, many “low” or “reduced” calorie foods for overweight companionanimals have been developed and are commercially available for thecontrol of calorie intake, prevention of weight gain or for thepromotion of weight loss. One strategy in weight loss involves highprotein diets with high protein to calorie ratios in order to reduce theamount of body fat in humans. A similar approach has been used incompanion animal products (e.g. PRESCRIPTION DIET® FELINE M/D®, Hill'sPet Nutrition, Topeka, Kans.). High protein diets have proven to beeffective in weight loss in cats; however high protein foods have hadmixed results when applied to canine weight management programs.Treatment strategies also include increasing the fiber and/or proteincontent while reducing the fat in the food. Depending on the fibersource, the fiber can induce satiety via gut distention or throughfeedback mechanisms (e.g., GLP-1). Fiber can be effective in reducingthe digestibility of food resulting in a lower availability of highcalorie nutrient components (i.e. fat and carbohydrates).

Despite the availability of such pet food formulations, however, theneed remains for the development of additional formulations comprisinginnovative ingredients and nutrients for preventing or treating obesityin companion animals. For example, one problem with weight loss is thatlean muscle mass is commonly lost as a component of total body weightloss even though it is not the target tissue. Thus, there is a need forcompositions which can cause weight loss in animals without causing lossof lean muscle mass.

We have now surprisingly discovered that a weight loss compositionformulated to include a specific balance of essential and limiting aminoacids can cause weight loss that is characterized by a preservation orgain of lean muscle. Thus, as contemplated herein, the compositions ofthe present invention may be useful to prevent or treat obesity in ananimal without the concomitant loss of lean muscle in the animal.

Essential amino acids are amino acids that cannot be synthesized denovo, or in sufficient quantities by an organism and thus must besupplied in the diet. Essential amino acids vary from species tospecies, depending upon the organism's metabolism. For example, it isgenerally understood that the essential amino acids for dogs and cats(and humans) are phenylalanine, leucine, methionine, lysine, isoleucine,valine, threonine, tryptophan, histidine and arginine. In addition,taurine, while technically not an amino acid but a derivative ofcysteine, is an essential nutrient for cats. A balanced diet can provideall the essential amino acids, however, there are certain essentialamino acids that are more critical, as a diet deficient in one of themwill limit the usefulness of the others, even if the other essentialamino acids are present in sufficient quantities. Generally, theselimiting amino acids are methionine, cysteine, tryptophan, and lysine.

SUMMARY OF THE INVENTION

We have identified the positive effects of balancing essential aminoacids in weight loss compositions. Specifically, this includes balancingthe quantity of lysine to leucine, methionine, methionine+cysteine,and/or phenylalanine+tyrosine. Particularly, the formulations of thepresent invention relate to compositions that are useful to prevent andtreat obesity in an animal, and preserve and cause lean muscle gain inan animal. In one embodiment, the composition is a pet food. In anotherembodiment, the composition is a wet pet food. In still anotherembodiment, the composition is a dry pet food.

In accordance with the present invention, Composition 1.0 is providedcomprising:

-   -   about 1.4 to about 2.1% lysine, wherein the composition has    -   a leucine to lysine ratio of about 1.7 to about 2.7,    -   a methionine+cysteine to lysine ratio of about 0.5 to about 1.5,    -   a phenylalanine+tyrosine to lysine ratio of about 1.3 to about        2.1, and    -   about 4 to about 8 grams of lysine per Mcal.

Additional compositions of the present invention may comprise any of thefollowing:

-   -   1.1. Composition 1 further comprising about 20 to about 30%,        about 22 to about 28%, or about 24 to about 26% dietary fiber;    -   1.2. Compositions 1 or 1.1 further comprising about 8 to about        14%, about 9 to about 13%, about 10 to about 12%, or about 10.3%        to about 11.6% crude fiber;    -   1.3. Any of the preceding compositions further comprising about        1.2 to about 4.0%, about 1.3 to about 3.6%, about 1.4 to about        3.3%, about 1.5 to about 3.1%, about 3.0%, or about 1.6% soluble        fiber;    -   1.4. Any of the preceding compositions comprising about 4 to        about 7, about 4.2 to about 6.8, about 4.7 to about 5.8, or        about 5.0 to about 5.6 grams of lysine per Mcal;    -   1.5. Any of the preceding compositions comprising about 1.5% to        about 1.9% lysine, about 1.6% to about 1.8% lysine, or about        1.7% lysine;    -   1.6. Any of the preceding compositions comprising a leucine to        lysine ratio of about 2.0 to about 2.4, about 2.1 to about 2.3,        or about 2.2;    -   1.7. Any of the preceding compositions comprising a        methionine+cysteine to lysine ratio of about 0.8 to about 1.2,        about 0.86 to about 1.1, about 0.90 to about 1.0, or about 0.95        to about 0.98;    -   1.8. Any of the preceding compositions comprising a        phenylalanine+tyrosine to lysine ratio of about 1.5 to about        1.9, about 1.6 to about 1.8, or about 1.6 to about 1.7;    -   1.9. Any of the preceding compositions comprising a tryptophan        to lysine ratio of about 0.1 to about 0.2, about 0.12 to about        0.18, about 0.13 to about 0.17, or about 0.14 to about 0.16;    -   1.10. Any of the preceding compositions comprising a threonine        to lysine ratio of about 0.5 to about 0.9, about 0.6 to about        0.8, or about 0.7;    -   1.11. Any of the preceding compositions comprising an arginine        to lysine ratio of about 0.75 to about 1.2, about 0.85 to about        1.1, preferably about 0.89 to about 1.1, or about 0.94 to about        1.0.    -   1.12. Any of the preceding compositions comprising an isoleucine        to lysine ratio of about 0.51 to about 0.82, about 0.58 to about        0.74, about 0.61 to about 0.71, about 0.68, or about 0.64;    -   1.13. Any of the preceding compositions comprising a valine to        lysine ratio about 0.6 to about 1.0, about 0.7 to about 0.9,        about 0.7 to about 0.8, or about 0.76 to about 0.80;    -   1.14. Any of the preceding compositions comprising a histidine        to lysine ratio about 0.3 to about 0.5, about 0.35 to about        0.44, about 0.37 to about 0.41, or about 0.40;    -   1.15. Any of the preceding compositions comprising a methionine        to lysine ratio of about 0.5 to about 0.9, about 0.6 to about        0.8, about 0.67 to about 0.76, or about 0.70 to about 0.73;    -   1.16. Any of the preceding compositions comprising a        metabolizable energy content of about 2600 to about 3950        Kcal/kg; about 2900 to about 3610 Kcal/kg; about 3080 to about        3450 Kcal/kg; or about 3240 to about 3280 Kcal/kg;    -   1.17. Any of the preceding compositions comprising about 75 to        about 200 ppm, or about 100 to about 150 ppm manganese;    -   1.18. Any of the preceding compositions comprising about 200 to        about 500 ppm, about 250 to about 400 ppm, or about 300 to about        350 ppm L-carnitine;    -   1.19. Any of the preceding compositions having about 24 to about        41%, or about 28 to about 37% crude protein;    -   1.20. Any of the preceding compositions comprising about 6.3 to        about 11%, or about 7.5 to about 10% fat;    -   1.21. Any of the preceding compositions comprising about 4.6% to        about 7.0%, or about 5.5 to about 6.6% ash;    -   1.22. Any of the preceding compositions comprising about 27 to        about 45%, about 31 to about 39%, or about 33% to about 37%        carbohydrate; and    -   1.23. Any of the preceding compositions being a dry food, or        further comprising a moisture content of about 5.3 to about        8.4%, or about 6.3% to about 7.4%.

In another embodiment of the present invention, Composition 2.0 isprovided comprising:

-   -   about 24 to about 41% crude protein;    -   about 20 to about 32% dietary fiber;    -   leucine:lysine ratio of about 2 to about 3;    -   about 1.2 to about 1.7% methionine; and    -   about 50 to about 500 ppm manganese; and    -   about 4.6 to about 6.8 grams of lysine per Mcal.

Additional compositions of the present invention may comprise any of thefollowing:

-   -   2.1. Composition 2.0 having about 22 to about 29%, or about 24        to about 27% dietary fiber;    -   2.2. Composition 2.0 or 2.1 having about 1.2 to about 4.0%, or        about 2 to about 3% soluble fiber;    -   2.3. Any of compositions 2.0-2.2 having about 21 to about 27%,        or about 23 to about 25% insoluble fiber;    -   2.4. Any of compositions 2.0-2.3 wherein the crude protein is        about 33 to about 36%, or about 35%;    -   2.5. Any of compositions 2.0-2.4 having about 5.1 to about 6.3        grams of lysine per Mcal; about 5.4 to about 6.0 grams of lysine        per Mcal; or about 5.7 grams of lysine per Mcal.    -   2.6. Any of compositions 2.0-2.5 having about 1.3% to about        1.6%, or about 1.4 to about 1.5% methionine;    -   2.7. Any of compositions 2.0-2.6 having about 75 to about 200        ppm manganese; or about 100 to about 150 ppm manganese;    -   2.8. Any of compositions 2.0-2.7 having about 200 to about 500        ppm carnitine; about 250 to about 400 ppm carnitine; or having        about 300 to 350 ppm carnitine;    -   2.9. Any of compositions 2.0-2.8 having a methionine+cysteine to        lysine ratio of about 1:1.25 to about 1.75:1; or a        methionine+cysteine to lysine ratio of about 1:1;    -   2.10. Any of compositions 2.0-2.9 having a leucine to lysine        ratio of about 1.4 to about 2.6, about 1.8 to about 2.2, or        about 2;    -   2.11. Any of compositions 2.0-2.10 comprising about 1 to about        10%, about 3 to about 7%, or about 4 to about 6% ash;    -   2.12. Any of compositions 2.0-2.11 having about 2 to about 13%,        about 8 to about 11%, or about 5 to about 7% fat;    -   2.13. Any of compositions 2.0-2.12 having a metabolizable energy        content of about 2000 to about 5000 kcal/kg, about 2480 to about        3720 kcal/kg, about 2800 to about 3400 kcal/kg, or about 3100        kcal/kg.    -   2.14. Any of compositions 2.0-2.13 being a wet food or having a        moisture content of about 70% to about 90%.    -   2.15. Composition 2.14 having metabolizable energy content of        about 720 to about 1080 kcal/kg, about 810 to about 990 kcal/kg,        or about 900 kcal/kg on a wet matter basis.

In another aspect, the invention relates to methods to prevent or treatobesity in an animal without concomitant loss of lean muscle mass byadministering to said animal any of compositions 1.0-2.15 in aneffective amount to prevent or treat obesity in said animal. Thecompositions may be administered to the animals for an effective amountof time.

In another aspect, the invention relates to a method for thepreservation or gain of lean muscle in an animal by administering to theanimal an effective amount of any of compositions 1.0-2.15. Thecompositions may be administered to the animal for an effective amountof time.

The compositions and methods are useful for treating animals,specifically, companion animals, preferably dogs and cats, morepreferably, dogs. The animals may be overweight, normal/ideal weight, orunderweight.

Additional or alternative advantages and benefits of the presentinvention will be apparent to one of skill in the art.

DETAILED DESCRIPTION OF THE INVENTION

It is contemplated that the invention described herein is not limited tothe particular methodology, protocols, and reagents described as thesemay vary. It is also to be understood that the terminology used hereinis for the purpose of describing particular embodiments only, and is notintended to limit the scope of the present invention in any way.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meanings as commonly understood by one of ordinary skillin the art to which this invention belongs. All patents, patentapplications, publications, and other references cited or referred toherein are incorporated by reference for all purposes.

As used herein and in the appended claims, the singular forms “a”, “an”,and “the” include plural reference unless the context clearly dictatesotherwise.

As used herein, the terms “overweight”, “fat”, “obese”, “obesity” andlike terms refer to a body weight condition of an animal that is morethan its' ideal weight. For example, the term “fat” as applied to ananimal can mean any animal that is determined to have an excess amountof body adipose tissue or an animal that is prone to developing anexcess amount of body adipose tissue using techniques and methods knownto veterinary care professionals and others of skill in the art. Forexample, an animal is considered “fat” if (1) the animal has a Body MassIndex (BMI) of 25 or more (a number considered to include “overweight”and “obese” animals in some methods of characterizing animalconditions), (2) the animal's weight is 15% or more than its “ideal”body weight as defined by veterinary care professionals, or as known toone of skill in the art, (3) an animal's percent body fat is 27% or moreas determined by dual-energy X-ray absorptiometry (“DEXA”), or (4) ananimal has a body condition score (“BCS”) of more than 3 on a scale from1 to 5 as determined by one of skill in the art using the methoddisclosed in “Small Animal Clinical Nutrition”, 4^(th) Edition, inChapter 13 (ISBN 0-945837-05-4) or its equivalent using other BCSmethods. In some cases, animals that are 20% or more over ideal bodyweight are considered obese.

As used herein, “treatment of obesity” refers to the reduction of bodyweight of an obese animal until the animal has achieved its ideal bodyweight, as determined according to conventional methods, e.g., byadministering an effective amount of a composition of the presentinvention to an animal. “Prevention of obesity” refers to preventing ananimal from attaining a body weight condition that would be deemed byone of skill in the art as being more than ideal for the animal, e.g.,by administering an effective amount of a composition of the presentinvention to the animal.

As used herein, “an amount effective”, “an effective amount”, and liketerms refer to that amount of a compound, material or composition asdescribed herein that may be effective to achieve a particularbiological result. Such results may include, but are not limited to, thetreatment and/or prevention of obesity and/or the preservation or gainof lean muscle mass. Such effective activity may be achieved, forexample, by administration of compositions of the present invention toan animal. An effective amount may be based on several factors,including an animal's ideal weight, the metabolizable energy of thecomposition, and frequency of feeding the animal compositions of thepresent invention, e.g., once, twice, or three times daily, and othercompositions fed to the animal.

As used herein, an “effective amount of time” may be determined byobserving or measuring the weight, weight loss, or lean muscle gain inan animal, and may be determined by one of skill in the art withoutundue experimentation.

The present invention relates to any animal, preferably a mammal, morepreferably a companion animal. The term “companion animal” refers to anyanimal that lives in close association with humans and includes, but isnot limited to, canines and felines of any breed. For example, it iscontemplated herein that this term may also encompass any animal whosediet may be controlled by humans and which may benefit from feeding theformulations disclosed herein. These animals may include, for example,domesticated farm animals (e.g. cattle, horses, swine, etc.) as well asundomesticated animals held in captivity, e.g. in zoological parks andthe like. Preferably, companion animals are cats and dogs, preferablydogs.

All percentages expressed herein are on a weight by dry matter basisunless specifically stated otherwise.

Without being limited to any theory or particular mode of action, thepresent invention is based on the surprising discovery that certaincompositions can be used to prevent and/or treat obesity whilepreserving or causing a gain in lean muscle mass by balancing the lysinecontent of the composition in particular ratios to other amino acids isthe composition. Preferably, lysine is balanced to one or more essentialamino acids (e.g., phenylalanine, leucine, methionine, isoleucine,valine, threonine, tryptophan, histidine and arginine). More preferably,lysine is balanced to one or more essential amino acids, including oneor more limiting amino acids (methionine, cysteine, tryptophan). Thelysine ratio may be expressed against one or more amino acids. Balancingthe ratio of lysine to metabolizable energy is also important in thepresent invention.

As contemplated herein, the compositions of the present invention aremeant to encompass nutritionally complete and balanced pet foodcompositions. Nutritionally complete and balanced pet food compositionsare familiar to one of skill in the art. For example, nutrients andingredients such as those disclosed herein as well as others suitablefor animal feed compositions, and recommended amounts thereof, may befound, for example, in the Official Publication of the Associate ofAmerican Feed Control Officials (“AAFCO”), Inc., Nutrient Requirementsof Dogs and Cats, 2006.

Protein may be supplied by any of a variety of sources known by thoseskilled in the art, including plant sources, animal sources, or both.Animal sources include, for example, meat, meat by-products, seafood,dairy, eggs, etc. Meats include, for example, the flesh of poultry,fish, and mammals (e.g., cattle, pigs, sheep, goats, and the like). Meatby-products include, for example, lungs, kidneys, brain, livers, andstomachs and intestines (freed of all or essentially all theircontents). The protein can be intact, almost completely hydrolyzed, orpartially hydrolyzed. Protein content of foods may be determined by anynumber of methods known by those of skill in the art, for example, aspublished by the Association of Official Analytical Chemists in OfficialMethods of Analysis (“OMA”), method 988.05. The amount of “crudeprotein” in a composition disclosed herein may be determined based onthe amount of nitrogen in the composition according to methods familiarto one of skill in the art.

Fat can be supplied by any of a variety of sources known by thoseskilled in the art, including meat, meat by-products, fish oil, andplants. Plant fat sources include wheat, flaxseed, rye, barley, rice,sorghum, corn, oats, millet, wheat germ, corn germ, soybeans, peanuts,and cottonseed, as well as oils derived from these and other plant fatsources. Fat content of foods may be determined by any number of methodsknown by those of skill in the art, such as by OMA methods 920.39,954.02 and 960.39.

Carbohydrate may be supplied by any of a variety of sources known bythose skilled in the art, including oat fiber, cellulose, peanut hulls,beet pulp, parboiled rice, corn starch, corn gluten meal, and anycombination of those sources. Grains supplying carbohydrate include, butare not limited to, wheat, corn, barley, and rice. Carbohydrate contentof foods may be determined by any number of methods known by those ofskill in the art. Generally, carbohydrate percentage may be calculatedas nitrogen free extract (“NFE”), which may be calculated as follows:NFE=100%−moisture %−protein %−fat %−ash %−crude fiber %.

Dietary fiber refers to components of a plant which are resistant todigestion by an animal's digestive enzymes. Dietary fiber components offoods may be determined by any number of methods known by those of skillin the art, such as OMA method 991.43/32.1.17 (1994). Dietary fiberincludes soluble and insoluble fibers.

Soluble fiber are resistant to digestion and absorption in the smallintestine and undergo complete or partial fermentation in the largeintestine, e.g., beet pulp, guar gum, chicory root, psyllium, pectin,blueberry, cranberry, squash, apples, oats, beans, citrus, barley, orpeas. Insoluble fiber may be supplied by any of a variety of sources,including cellulose, whole wheat products, wheat oat, corn bran, flaxseed, grapes, celery, green beans, cauliflower, potato skins, fruitskins, vegetable skins, peanut hulls, and soy fiber. Soluble andinsoluble fiber content of foods may be determined by any number ofmethods known by those of skill in the art, preferably OMA method991.43/32.1.17 (1994).

Crude fiber includes indigestible components contained in cell walls andcell contents of plants such as grains, e.g., hulls of grains such asrice, corn, and beans. Crude fiber content of foods may be determined byany number of methods known by those of skill in the art, such as by OMA16th edition method 962.09/4.6.01.

The amino acid percentage of the compositions in the present inventionmay be determined by any means known in the art. For example, the valuesfor the total amount of lysine provided by the invention can bedetermined using methods known in the art, including OMA methods 975.44,988.15 and 994.12 (1995). As another example, tryptophan content may bedetermined according to OMA method 988.15 (1995); methionine, cysteineand other amino acid content may be determined according to OMA method994.12 (1995). Amino acid content may also be determined according toOMA method 982.30. The essential amino acids in the present compositionsmay be supplied by any number of sources, including crude protein, oraddition of free amino acids to the composition.

Metabolizable energy (ME) of a diet is the energy available to an animalupon consumption of the diet after subtracting the energy excreted infeces, urine, and combustible gases. Metabolizable energy values may bedetermined by methods known by those skilled in the art, such asdetailed in Association of American Feed Control Officials: OfficialPublication, Atlanta, Ga., pages 160-165 (2006).

“Ash” consists of compounds that are not organic or water, generallyproduced by combustion of biological materials. Ash may be determined byany number of methods known by those of skill in the art, such as OMAmethod 942.05.

Carnitine, or L-carnitine, is a vitamin-like compound synthesized in thebody from lysine and methionine. Carnitine may be naturally present iningredients of the of the present invention, or carnitine may be addedto the compositions. Methods of measuring carnitine are known in theart, such as described in R. Parvin and S. V. Pande, “Microdeterminationof (−)Carnitine and Carnitine Acetyltransferases Activity,” ANALYTICALBIOCHEMISTRY, vol. 79, pp. 190-201 (1977).

The compositions of the present invention also contain one or moreminerals and/or trace elements, e.g., calcium, phosphorus, sodium,potassium, magnesium, manganese, copper, zinc, choline, or iron salts.One preferred trace element is manganese. Manganese is essential to ahost of enzymes as a cofactor, which may regulate the metabolism offoods, including proteins, fats, and carbohydrates. Such enzymes mayinclude oxidoreductases, transferases, hydrolases, lyases, isomerases,ligases, lectins, and integrins. Manganese also affects bone developmentand neurological function. Manganese may be naturally present in thecomponents of the compositions, or it may be added to compositions.Methods of measuring manganese content in a composition are well knownto those of skill in the art, such as OMA 965.17 and 985.01.

The compositions of the present invention may also include vitamins andminerals in amounts required to avoid deficiency and maintain health.These amounts, and methods of measurement are known by those skilled inthe art. For example, AAFCO provides recommended amounts of suchingredients for dogs and cats. As contemplated herein, useful vitaminsmay include, but are not limited to, vitamin A, vitamin B₁, vitamin B₂,vitamin B₆, vitamin B₁₂, vitamin C, vitamin D, vitamin E, vitamin H(biotin), vitamin K, folic acid, inositol, niacin, and pantothenic acid.

The compositions of the present invention may additionally compriseadditives, stabilizers, fillers, thickeners, flavorants, palatabilityenhancers and colorants in amounts and combinations familiar to one ofskill in the art.

In one embodiment, the compositions are in the form of a food or petfood. In another embodiment, the composition is a treat. Treats areknown to those skilled in the art, and can include, for example,compositions that are given to an animal to eat during non-meal time,e.g., a dog biscuit.

While foods of any consistency or moisture content are contemplated,preferably the compositions of the present invention may be, forexample, a wet or dry animal food composition. “Wet” food refers to foodwhich has a moisture content of about 70 to about a 90%. “Dry” foodrefers to compositions with about 5 to about 15% moisture content and isoften manufactured in the form of small bits or kibbles. Alsocontemplated herein are compositions that may comprise components ofvarious consistency as well as components that may include more than oneconsistency, for example, soft, chewy meat-like particles as well askibble having an outer cereal component and an inner cream component asdescribed in, e.g., U.S. Pat. No. 6,517,877. The kibble may then bedried and optionally coated with one or more topical coatings known bythose skilled in the art, for example, flavors, fats, oils, powders, andthe like.

In accordance with the present invention, compositions 1.0-2.15 can beadministered to an animal to prevent or treat obesity in the animal,preferably without loss of lean muscle mass. Prevention of obesity maybe accomplished by administering to an animal an effective amount of thecompositions of the present invention over a period of time, monitoringthe animal's weight adipose tissue, and lean muscle mass, and adjustingthe amount of food fed to the animal to prevent the animal from gainingexcess adipose tissue and preserve or cause a gain in lean muscle mass.Treatment of obesity may be accomplished by administering to an animalan effective amount of the compositions of the present invention andmonitoring the animal's adipose tissue content until the animal has lostsufficient adipose tissue to be considered an ideal weight, asunderstood by one of skill in the art.

In accordance with the present invention, compositions 1-2.15 can be fedto an animal, not only to treat obesity without loss of lean muscle, butto cause gain of lean muscle in an animal in need thereof. Said animalneed not be obese; gain of lean muscle may be desirable in animals whoselean muscle mass is less than ideal due to any number of factorsincluding, e.g., age, disease, or malnutrition. Gain of lean muscle maybe accomplished by administering to an animal an effective amount of thecompositions of the present invention while monitoring the animal's leanmuscle content until the animal has gained a sufficient amount of leanmuscle to be considered an ideal weight, or sufficient as determined byone of skill in the art.

The compositions and methods of the present invention may be part of anoverall weight loss program, for example, the compositions and methodsmay be used in combination with regular exercise and restricted accessto treats, table scraps or other pet snacks.

The present invention also includes the use of any one of compositions1.0-2.15 to prevent or treat obesity, and/or to preserve lean muscle,and/or to cause gain of lean muscle. The present invention also includesthe use of any one of compositions 1.0-2.15 in the manufacture of a foodcomposition, preferably a pet food composition, more preferably a dogfood, to prevent or treat obesity, and/or to preserve lean muscle,and/or to cause gain of lean muscle.

EXAMPLES Example 1 Formulation of Compositions

The following compositions of Table 1 are formulated in accordance withthe Association of American Feed Control Officials 2005 nutrient guidefor dogs, balanced to meet adult maintenance requirements, and extrudedas a dry kibble. The contents of the compositions are analyzed bymethods known in the art.

TABLE 1 Control Formula A Formula B Crude Protein, % 28.34 33.87 33.42Crude Fat, % 9.65 8.54 9.05 Crude Fiber, % 20.87 10.33 11.57 TotalDietary Fiber, % 33.54 25.4 25.39 Soluble Fiber, % 0.98 3.01 1.61 Ash, %5.08 6.3 6.16 Calcium, % 0.79 0.93 0.93 Phosphorous, % 0.61 0.8 0.79Manganese, ppm 30 100 100 Lysine, % 1.51 1.74 1.70 Methionine, % 0.501.23 1.24 Methionine + Cysteine, % 0.83 1.65 1.67 Tryptophan, % 0.280.27 0.24 Threonine, % 1.07 1.24 1.22 Arginine, % 1.55 1.64 1.71Isoleucine, % 1.02 1.19 1.09 Valine, % 1.23 1.39 1.29 Leucine, % 2.213.82 3.74 Histidine, % 0.60 0.69 0.67 Phenylalanine + Tyrosine, % 1.812.91 2.92 Carnitine (Added), ppm 300 300 300 Linolenic acid, % 0.32 0.960.29 Linoleic acid, % 3.04 2.03 2.90 Metabolizable Energy, 2940 32833241 kcal/kg Lysine:Calorie 5.14 5.30 5.25 Methionine + cysteine:Lysine0.55 0.95 0.98 Tryptophan:Lysine 0.19 0.16 0.14 Threonine:Lysine 0.710.71 0.72 Arginine:Lysine 1.03 0.94 1.01 Isoleucine:Lysine 0.68 0.680.64 Valine:Lysine 0.81 0.80 0.76 Leucine:Lysine 1.46 2.20 2.20Histidine:Lysine 0.40 0.40 0.39 Phenylalanine + Tyrosine:Lysine 1.201.67 1.72

Example 2 Canine Weight Loss Study

Thirty obese dogs (beagles) are utilized in a 120 day weight loss study.All dogs have a percent body fat (total weight) of greater than 26%. Thedogs are randomly divided into three groups, and fed either Control,Formula A, or Formula B. Dogs are fed amounts according to their idealbody weight, i.e., the number of kcal per day according to a dog's idealbody weight and is calculated as follows:

a dog's ideal body weight is calculated as:

$W_{I} = \frac{W_{0} - {W_{0}\left( {F_{0}/100} \right)}}{\left( {1 - {F_{I}/100}} \right)}$wherein W₁=ideal weight (kg), W₀=initial weight (kg), F₀=measured bodyfat (%), and F₁=ideal body fat (%). Dogs utilized in the study aredeemed to have an ideal body fat of 20%. The number of kcal fed per dayaccording to a dog's ideal body weight is calculated as follows:1.6×(70*W ₁)^(3/4)=kcal/day fed to a dog according to its ideal bodyweight.

The amount of food fed per dog is determined by dividing the number ofkcal per day for a dog according to ideal body weight by the number ofkcal per kilogram of food, i.e., kcal/kg of Control, Formula A, andFormula B.

During the study, each dog undergoes DEXA scans (DXA-QDR-4500, Hologic,Inc., Waltham, Mass.) at days 0, 30, 60, 90, and 120 days to measurelean muscle, and body fat. At days 0 and 30, n=10 for dogs each fedControl, Formula A, and Formula B compositions. Dogs are removed fromthe study when they achieve less than 25% body fat. At day 60, 4 dogsfed Formula A and 2 dogs fed Formula B are removed from the study. Thus,for data at day 90:

n=10 for dogs fed Control;

n=6 for dogs fed Formula A; and

n=8 for dogs fed formula B.

At day 90, 2 dogs fed Control, 4 dogs fed Formula A and 3 dogs fedFormula B are removed from the study. Thus, for data at day 120:

n=8 for dogs fed Control;

n=7 for dogs fed Formula A; and

n=5 for dogs fed Formula B.

Results of the study are provided in the following tables:

TABLE 2 Total body mass of dogs Total Weight (g) Control Formula AFormula B Day 0 15866 ± 920 16645 ± 920 17686 ± 920 Day 30 14797 ± 88115114 ± 881 16180 ± 881 Day 60 14598 ± 904 14539 ± 904 15739 ± 953 Day90 13815 ± 880  14820 ± 1136 16160 ± 984 Day 120  13977 ± 1016  15729 ±1659  15942 ± 1285 Change day 0 to 30 −1069 ± 262 −1531 ± 262 −1506 ±262 Change day 0 to 60 −1268 ± 314 −2105 ± 314 −2166 ± 331 Change day 0to 90 −2051 ± 291 −1809 ± 376 −2347 ± 326 Change day 0 to 120 −2456 ±349 −1892 ± 570 −2408 ± 441 Day 0 vs day 30* <0.01 <0.01 <0.01 Day 0 vsday 60* <0.01 <0.01 <0.01 Day 0 vs day 90* <0.01 <0.01 <0.01 Day 0 vsday 120* <0.01 <0.01 <0.01 *Probability of greater F value

TABLE 2A Analysis of dog body mass change Control vs. Control vs.Formula A vs Total Weight (g) Formula A* Formula B* Formula B* Day 0 NDND ND Day 30 ND ND ND Day 60 ND ND ND Day 90 ND ND 0.09 Day 120 ND ND NDChange day 0 to 30 ND ND ND Change day 0 to 60 0.07 0.06 ND Change day 0to 90 ND ND ND Change day 0 to 120 ND ND ND *Probability of greater Fvalue, ND = No difference

TABLE 3 Lean muscle mass of dogs Muscle (g) Control Formula A Formula BDay 0 9840 ± 563 10161 ± 563  10864 ± 563 Day 30 9266 ± 479 9775 ± 47910389 ± 479 Day 60 8713 ± 493 10502 ± 493  11250 ± 519 Day 90 9452 ± 4989843 ± 643 10997 ± 557 Day 120 9183 ± 507 9520 ± 828 10368 ± 641 Changeday 0 to 30 g −573 ± 159 −386 ± 159  −475 ± 159 Change day 0 to 60, g−1126 ± 155   341 ± 155  235 ± 163 Change day 0 to 90, g −387 ± 198 −153± 256  −284 ± 221 Change day 0 to 120, g −832 ± 255 −748 ± 416  −457 ±323 Day 0 vs Day 30* <0.01 0.02 <0.01 Day 0 vs day 60* <0.01 0.04 ND Day0 vs day 90*   0.06 ND ND Day 0 vs day 120* <0.01 ND ND *Probability ofgreater F value, ND = No difference

TABLE 3A Analysis of dog muscle mass change Control vs Control vsFormula A vs Muscle (g) Formula A* Formula B* Formula B* Day 0 ND ND NDDay 30 ND ND ND Day 60 0.02 <0.01 ND Day 90 ND   0.05 ND Day 120 ND NDND Change day 0 to 30 g ND ND ND Change day 0 to 60, g <0.01 <0.01 NDChange day 0 to 90, g ND ND ND Change day 0 to 120, g ND ND ND*Probability of greater F value, ND = No difference

TABLE 4 Fat mass of dogs Fat (g) Control Formula A Formula B Day 0 5602± 446 5997 ± 446 6321 ± 446 Day 30 5128 ± 503 4876 ± 503 5315 ± 503 Day60 5491 ± 528 3571 ± 528 4005 ± 557 Day 90 3964 ± 521 4520 ± 673 4680 ±583 Day 120 4395 ± 608 5761 ± 993 5103 ± 769 Change day 0 to 30 −474 ±212 −1121 ± 212  −1006 ± 212  Change day 0 to 60 −111 ± 284 −2426 ± 284 −2374 ± 299  Change day 0 to 90 −1638 ± 211  −1632 ± 273  −2021 ± 236 Change day 0 to 120 −1592 ± 249  −1104 ± 407  −1899 ± 315  Day 0 vs day30*   0.03 <0.01 <0.01 Day 0 vs day 60* ND <0.01 <0.01 Day 0 vs day 90*<0.01 <0.01 <0.01 Day 0 vs day 120* <0.01   0.02 <0.01 *Probability ofgreater F value, ND = No difference

TABLE 4A Analysis of fat mass change Control vs Control vs Formula A vsFat (g) Formula A* Formula B* Formula B* Day 0 ND ND ND Day 30 ND ND NDDay 60 0.02 0.06 ND Day 90 ND ND ND Day 120 ND ND ND Change day 0 to 300.04 0.09 ND Change day 0 to 60 <0.01   <0.01   ND Change day 0 to 90 NDND ND Change day 0 to 120 ND ND ND *Probability of greater F value, ND =No difference

The results indicate that although all animals lose lean muscle in thefirst 30 days of the study, animals fed Formulas A and B statisticallylose more adipose tissue than animals fed Control. The results alsoindicate that at day 60, animals fed Formulas A and B regain lean muscle(compared with Control).

Example 3 Formulation of Compositions

Compositions are formulated in accordance with the specifications ofTable 5 on a dry matter basis:

TABLE 5 Minimum Target Maximum Protein % 33 35 36 Soluble Fiber % 1.2 4Insoluble Fiber % 23 25 Dietary Fiber % 24 27 Lysine:energy (g/Mcal) 5.7Leucine:Lysine ratio 2 Methionine % 1.4 1.5 Manganese (ppm) 100Carnitine (ppm) 300 350

Example 4 Formulation of Dry Composition

The composition of Example 3 is formulated as a dry dog food having ametabolizable energy content of about 3100 kcal/kg.

Example 5 Formulation of Wet Composition

The composition of Example 3 is formulated as a wet dog food having ametabolizable energy content of about 900 kcal/kg on a wet matter basis.

While particular embodiments of the present invention have been shownand described herein, it will be apparent to those skilled in the artthat changes and modifications may be made without departing from thebroader aspects of invention.

What is claimed is:
 1. A composition comprising about 1.4 to about 2.1%lysine, wherein the composition has a leucine to lysine ratio of about1.7 to about 2.7, a methionine+cysteine to lysine ratio of about 0.5 toabout 1.5, a phenylalanine+tyrosine to lysine ratio of about 1.3 toabout 2.1, and about 4 to about 8 grams of lysine per Mcal, about 20 toabout 30% dietary fiber, and wherein the composition is formulated as afood or treat.
 2. The composition of claim 1, comprising about 8 toabout 14% crude fiber.
 3. The composition of claim 1, comprising about1.2 to about 4.0% soluble fiber.
 4. The composition of claim 1 havingabout 4.2 to about 6.8 grams of lysine per Mcal.
 5. The composition ofclaim 1 having about 1.5% to about 1.9% lysine.
 6. The composition ofclaim 1 having a leucine to lysine ratio of about 2.0 to about 2.4. 7.The composition of claim 1 having a methionine+cysteine to lysine ratioof about 0.8 to about 1.2.
 8. The composition of claim 1 having aphenylalanine+tyrosine to lysine ratio of about 1.5 to about 1.9.
 9. Thecomposition of claim 1 having a tryptophan to lysine ratio of about 0.1to about 0.2.
 10. The composition of claim 1 having a threonine tolysine ratio of about 0.5 to about 0.9.
 11. The composition of claim 1having an arginine to lysine ratio of about 0.75 to about 1.2.
 12. Thecomposition of claim 1, having an isoleucine to lysine ratio of about0.51 to about 0.82.
 13. The composition of claim 1 having a valine tolysine ratio of about 0.6 to about 1.0.
 14. The composition of claim 1having a histidine to lysine ratio of about 0.3 to about 0.5.
 15. Thecomposition of claim 1 having a methionine to lysine ratio of about 0.5to about 0.9.
 16. The composition of claim 1, having a metabolizableenergy content of about 2600 to about 3950 Kcal/kg.
 17. The compositionof claim 1, further comprising about 75 to about 200 ppm manganese. 18.The composition of claim 1, further comprising about 200 to about 500ppm L-carnitine.
 19. The composition of claim 1, further comprisingabout 24 to about 41% crude protein.
 20. A composition comprising: about24 to about 41% crude protein; about 20 to about 32% dietary fiber;leucine to lysine ratio of about 2 to about 3; about 1.2 to about 1.7%methionine; about 50 to about 500 ppm manganese; and about 4.6 to about6.8 grams of lysine per Mcal.
 21. The composition of claim 20 furthercomprising about 1.2 to about 4.0% soluble fiber.
 22. The composition ofclaim 1 further comprising about 21 to about 27% insoluble fiber. 23.The composition of claim 1 having about 5.1 to about 6.3 grams of lysineper Mcal.
 24. The composition of claim 1 having about 200 to about 500ppm L-carnitine.
 25. The composition of claim 1 further having amethionine+cysteine to lysine ratio of about 1:1.25 to about 1.75:1. 26.The composition of claim 1 having a leucine to lysine ratio of about 1.4to about 2.6.
 27. The composition of claim 1 being about 1 to about 10%ash.
 28. The composition of claim 1 having a metabolizable energycontent of about 2000 to about 5000 kcal/kg.
 29. The composition ofclaim 1 wherein the composition is a wet pet food.
 30. The compositionof claim 29 having metabolizable energy content of about 720 to about1080 kcal/kg on a wet matter basis.